The present invention relates to the treatment of hemorrhoids by elastic band ligation. More specifically the invention relates to an elastic band ligation device that is provided with an integrated obturator which provides for more controlled elastic band deployment and less discomfort for the patient.
Commonly assigned patent applications entitled ELASTIC BAND LIGATION DEVICE WITH LOCKING MECHANISM AND METHOD FOR TREATMENT OF HEMORRHOIDS (U.S. application Ser. No. 13/972,168) and ELASTIC BAND LIGATION DEVICE WITH ANTI-PINCH FEATURE AND METHOD FOR TREATMENT OF HEMORRHOIDS (U.S. application Ser. No. 13/972,202) are filed simultaneously herewith, the entire disclosures of which are hereby incorporated by reference herewith.
Treatment of hemorrhoids by elastic band ligation typically involves placing an elastic band on hemorrhoidal tissue in the rectum well above the “dentate line” (the junction of the sensitive squamous epithelium known as the “anoderm” and the insensitive lining of the rectum known as the “mucosa”), where there is little sensation. The tissue trapped in the band is cut off from its blood supply, degenerates and is sloughed, and the elastic band along with the sloughed tissue is passed with bowel motions. More importantly, however, the resulting healing process causes the tissue in the vicinity to become fixed, and prolapse of the hemorrhoidal tissue is minimized. This fixation of the tissue serves to eliminate the hemorrhoidal symptoms.
Many devices exist on the market utilizing the elastic band ligation technique. Examples are U.S. Pat. No. 5,203,863 to Bidoia, U.S. Pat. No. 5,122,149 to Broome, U.S. Pat. No. 5,158,563 to Cosman and U.S. Pat. No. 5,741,273 to O'Regan. The devices disclosed in U.S. Pat. No. 5,203,863 to Bidoia, U.S. Pat. No. 5,122,149 to Broome, U.S. Pat. No. 5,158,563 to Cosman are generally designed to be used in conjunction with an instrument such as a proctoscope or anoscope to directly see the area to be banded. In some cases, it is necessary to employ an assistant to hold the proctoscope or anoscope. However, the use of these scopes, which are generally larger in diameter than banding apparatus, can cause considerable discomfort to a patient and more specifically to one who is suffering symptoms of hemorrhoids and other associated issues.
The device disclosed in U.S. Pat. No. 5,741,273 to O'Regan relates to an elastic band ligation device for treatment of hemorrhoids that may be used without directly seeing the site for banding. Thus, it may be used without a proctoscope or anoscope or any other type of scope or viewing technique. Therefore, because the device can be inserted into the rectum and positioned appropriately without simultaneous visualization, or the need for any type of scope, the banding procedure performed in this manner causes less discomfort to the patient. This technique also allows for a more proximal placement of the elastic band, which increases the technique's efficacy as well as causing less discomfort and fewer complications. This device has a suction device incorporated therein to draw hemorrhoidal tissue into an aperture for banding without requiring a second operator or connection to an aspirator.
Ligation is typically performed by initially inspecting the site through a small scope such as a sigmoidoscope, anoscope, proctoscope or other type of scope and making a mental note as to the area where the band should optimally be placed. The scope is then removed and the ligation device is placed in the rectum. This is known as the “Blind” or “Touch” technique.
An alternative application is to visualize the area with an anoscope and insert the banding through the lumen of the anoscope and band directly. This can be done if the operator prefers a direct visual approach. This is known as the “Trans-anoscopic” or “visual” technique.
The front end of the device is inserted well past the site for banding. Then, the device is gently withdrawn back to the banding site, when a palpable “ridge” on the outer surface of the outer tubular member (“pusher sleeve”) can be felt at the anal verge. The device then is angled acutely to point in the direction of the hemorrhoid to be treated. In larger patients, the operator may choose to place the device 1-2 cm further in through the anus prior to “aiming” the device towards the hemorrhoid to be treated.
However, it has been found that prior devices suffer from the drawback that the elastic band(s) may undergo premature deployment, with the result that it is necessary to withdraw the device, recover the deployed elastic band within the rectum and begin the procedure again. This gives rise to delays and additional discomfort to the patient. A need exists, therefore, for an improved elastic band ligation device in which premature deployment of the elastic band is prevented. The present invention seeks to satisfy that need.